Amoxicillin/clavulanic acid Sandoz 100 mg/ml + 12.5 mg/ml powder for oral suspension EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Amoxicillin/Clavulanic Acid Sandoz is and what it is used for
- 2. What you need to know before starting to use Amoxicillin/Clavulanic Acid Sandoz
- 3. How to use Amoxicillin/Clavulanic Acid Sandoz
- 4. Possible adverse effects
- 5. Storage of Amoxicillin/Clavulanic Acid Sandoz
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Amoxicillin/Clavulanic acid Sandoz 100 mg/ml + 12.5 mg/ml powder for oral suspension EFG
Read the entire leaflet carefully before your child starts taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine is usually prescribed for infants and children, and you should not give it to other people, even if they have the same symptoms as your child, as it may harm them.
- If your child experiences any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Amoxicillin/Clavulanic acid Sandoz is and what it is used for
- What you need to know before using Amoxicillin/Clavulanic acid Sandoz
- How to use Amoxicillin/Clavulanic acid Sandoz
- Possible side effects
- How to store Amoxicillin/Clavulanic acid Sandoz
- Contents of the pack and other information
1. What Amoxicillin/Clavulanic Acid Sandoz is and what it is used for
Pharmacotherapeutic group: Combinations of penicillins, including beta-lactamase inhibitors, ATC code: J01CR02.
Amoxicillin/Clavulanic Acid is an antibiotic that kills bacteria causing infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which can sometimes become ineffective (inactivated). The other medicine (clavulanic acid) prevents this from happening.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.
It is important that you follow your doctor's instructions regarding dosage, frequency, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.
Amoxicillin/Clavulanic Acid 100 mg/ml + 12.5 mg/ml powder for oral suspension is used in infants and children for the treatment of the following infections:
- middle ear and paranasal sinus infections,
- respiratory tract infections,
- urinary tract infections,
- skin and soft tissue infections including dental infections,
- bone and joint infections.
2. What you need to know before starting to use Amoxicillin/Clavulanic Acid Sandoz
Do not give Amoxicillin/Clavulanic Acid Sandoz to your child:
- if he or she is allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or to any of the other ingredients of this medicine (listed in section 6),
- if he or she has ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include skin rash or swelling of the face or neck,
- if he or she has ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.
Do not give Amoxicillin/Clavulanic Acid Sandoz to your child if any of the above apply.
Before starting treatment with this medicine, if you are unsure, consult your child’s doctor, pharmacist, or nurse.
Warnings and precautions
Talk to your child’s doctor or pharmacist before administering amoxicillin/clavulanic acid to your child if your child:
- has infectious mononucleosis,
- is receiving treatment for liver or kidney problems,
- does not urinate regularly.
If you are unsure whether any of the above conditions affect your child, inform your doctor or pharmacist before giving amoxicillin/clavulanic acid to your child.
In some cases, your doctor may investigate the type of bacteria causing your child’s infection. Depending on the results, your child may receive a different dose of amoxicillin/clavulanic acid or another medicine.
Symptoms to watch for
Amoxicillin/clavulanic acid may worsen certain pre-existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be alert for certain symptoms while your child is taking this medicine to reduce the risk of complications. See “Symptoms to watch for” in section 4.
Blood and urine tests
If your child is undergoing blood tests (such as studies of red blood cells or tests to check liver function) or urine tests (to monitor glucose levels), inform your doctor or nurse that your child is taking amoxicillin/clavulanic acid. This is because this medicine may alter the results of these types of tests.
Other medicines and Amoxicillin/Clavulanic Acid Sandoz
Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal medicines.
If your child is taking allopurinol (for the treatment of gout) with amoxicillin/clavulanic acid, he or she may be more likely to develop a skin allergic reaction.
If your child is taking probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended; your doctor may adjust the dose of amoxicillin/clavulanic acid.
If anticoagulants (such as warfarin) are taken with amoxicillin/clavulanic acid, more blood tests will be needed.
Amoxicillin/clavulanic acid may affect the action of methotrexate (a medicine used to treat cancer and severe psoriasis); penicillins may reduce methotrexate excretion and cause a potential increase in adverse effects.
Amoxicillin/clavulanic acid may affect the efficacy of mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients).
Pregnancy and breastfeeding
This subsection does not apply to Amoxicillin/Clavulanic Acid Sandoz, as this medicine is intended for use in children weighing less than 40 kg; however, the following information applies to the active ingredients, amoxicillin/clavulanic acid.
Pregnancy
This medicine should only be used during pregnancy on the advice of your doctor. If you find out you are pregnant while being treated, consult your doctor, as only he or she can decide whether you should continue.
An increased risk of intestinal inflammation (enterocolitis) has been observed in neonates born to women at risk of imminent delivery who received amoxicillin/clavulanic acid.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Breastfeeding
Breastfeeding is possible while taking this medicine. If your newborn baby develops problems such as diarrhea, skin rash, or candidiasis (a condition caused by certain microscopic fungi), inform your doctor immediately, as he or she will advise you on what to do, since these effects in your baby may be due to this medicine.
Driving and use of machines
This subsection does not apply to Amoxicillin/Clavulanic Acid Sandoz, as this medicine is intended for use in children weighing less than 40 kg; however, the following information applies to the active ingredients, amoxicillin/clavulanic acid.
This medicine may cause adverse effects whose symptoms may affect your ability to drive. Do not drive a vehicle or operate machinery unless you feel completely well.
Amoxicillin/Clavulanic Acid Sandoz contains 3 mg of aspartame per ml of reconstituted solution
Aspartame contains a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
Amoxicillin/Clavulanic Acid Sandoz contains maltodextrin (a source of glucose)
If your doctor has informed you of an intolerance to certain sugars, consult him or her before taking this medicine. It may harm teeth.
Amoxicillin/Clavulanic Acid Sandoz contains potassium
This medicine contains 0.68 mg of potassium per dose, i.e., 2.5 mg per ml of oral suspension, which should be taken into account in patients with renal impairment or those on potassium-restricted diets.
3. How to use Amoxicillin/Clavulanic Acid Sandoz
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Dosage
Adults and children weighing 40 kg or more
This medicine is not normally recommended for adults and children weighing more than 40 kg. Consult your doctor or pharmacist.
Children weighing less than 40 kg
All doses are expressed based on the child's body weight in kilograms.
- Your doctor will advise you how much amoxicillin/clavulanic acid to give your baby or child.
- A plastic oral dosing syringe will be provided. You must use it to give the correct dose to your baby or child.
- The recommended dose is 40 mg/5 mg up to 80 mg/10 mg per kilogram of body weight per day, administered in three divided doses.
Patients with kidney or liver problems
- If your child has kidney problems, the dose may be reduced. Your doctor may choose a different formulation or another medicine.
- If your child has liver problems, blood tests will be performed more frequently to monitor liver function.
How to administer Amoxicillin/Clavulanic Acid Sandoz
Oral use.
Administer the medicine to your child preferably at the beginning of a meal or shortly before.
Once water has been added and between uses, keep the bottle refrigerated.
Shake the bottle well before each use.
The medicine is administered using an oral dosing syringe graduated in kg of body weight.
Distribute the doses evenly throughout the day, with at least 4 hours between doses. Do not administer 2 doses within 1 hour.
Do not give your child amoxicillin/clavulanic acid for longer than 2 weeks. If your child's symptoms persist, consult a doctor again.
INSTRUCTIONS FOR USE OF THE ORAL DOSING SYRINGE
The amount per dose is indicated on the plunger of the oral dosing syringe, graduated in kg according to the child's weight. Therefore, the dose can be read directly from the syringe graduations. The indicated weight corresponds to a single dose. It must be taken three times a day.
For example, the graduation 20 corresponds to the amount to be administered per dose to a child weighing 20 kg, three times a day.
For first use
- Fill with non-carbonated water up to the fill line. Shake well to obtain a homogeneous liquid. Refill with water if necessary.
- Insert the oral syringe into the bottle.
- Pull the plunger to the graduation corresponding to the child's weight. Read the weight in kg from the neck of the syringe. Remove the syringe from the bottle for administration. Note: do not pull the plunger again.
- Administer the medicine directly into the child's mouth or with a spoon.
- After each use, rinse the oral syringe thoroughly with water. Close the bottle carefully after each use.
- Return the bottle to the refrigerator after each use.
For each subsequent use
- Shake the bottle well before each use.
- Repeat steps 2 to 6 (see above).
Please note that this oral syringe should not be used to administer any other medication, as the calibration of this oral syringe is specific to this medication. |
3 doses per day.
For this antibiotic to be effective, it must be used regularly at the prescribed doses and for the length of time indicated by your doctor.
The disappearance of fever or any other symptom does not mean that your child is completely cured. Any feeling of tiredness is not due to the antibiotic treatment but to the infection itself. Reducing or stopping your child's treatment would have no effect on this feeling and would delay recovery.
If you give more Amoxicillin/Clavulanic acid Sandoz than you should
If you give your child too much amoxicillin/clavulanic acid, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Contact your child's doctor as soon as possible. Take the bottle along to show the doctor.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medication and the amount ingested.
If you forget to give amoxicillin/clavulanic acid to your child
If you forget to give your child a dose, give it as soon as you remember. Wait at least 4 hours before giving the next dose. Do not give a double dose to make up for missed doses.
If your child stops treatment with amoxicillin/clavulanic acid
Continue giving your child amoxicillin/clavulanic acid until the treatment is finished, even if he/she feels better. All doses are important to fight the infection. If some bacteria survive, they could cause the infection to recur.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur with this medicine:
Symptoms to watch for
Allergic reactions:
- skin rash,
- inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may affect other parts of the body,
- fever, joint pain, swollen glands in the neck, armpits, or groin,
- swelling, sometimes of the face or throat (angioedema), causing difficulty breathing,
- sudden malaise with a drop in blood pressure,
- chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome).
Contact your doctor immediately if your child experiences any of these symptoms.
Stop administering amoxicillin/clavulanic acid.
Inflammation of the large intestine
Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.
Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
DIES has mainly been reported in children receiving amoxicillin/clavulanic acid. It is a type of allergic reaction with the main symptom being repeated vomiting (1 to 4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
Contact your doctor as soon as possible for advice if your child has these symptoms.
Very common adverse effects
May affect more than 1 in 10 people:
- diarrhoea (in adults).
Common adverse effects
May affect up to 1 in 10 people:
- thrush (caused by a fungus, Candida, causing infections in the vagina, mouth, or mucous membranes),
- nausea, especially when high doses are taken,
If your child experiences these adverse effects, administer Amoxicillin/Clavulanic Acid Sandoz before meals.
- vomiting,
- diarrhoea (in children).
Uncommon adverse effects
May affect up to 1 in 100 people:
- skin rash, itching,
- increased itchy rash (urticarial weals),
- indigestion,
- dizziness,
- headache.
Uncommon adverse effects that may appear in blood tests
- increase in certain substances (enzymes) produced by the liver.
Rare adverse effects
May affect up to 1 in 1,000 people:
- skin rash, which may blister and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme).
If you experience any of these symptoms, consult your doctor urgently.
Rare adverse effects that may appear in blood tests
- low count of cells involved in blood clotting (platelets),
- low white blood cell count.
Frequency not known
Cannot be estimated from the available data.
- allergic reactions (see above),
- inflammation of the large intestine (see above),
- inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),
- severe skin reactions:
- widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (more than 30% of body surface – toxic epidermal necrolysis),
- widespread rash with small pus-filled blisters (exfoliative bullous dermatitis),
- red rash with bumps under the skin and blisters (exanthematous pustulosis),
- flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)),
- rash with blistering arranged in a ring with a crusted center or resembling a string of pearls (IgA linear disease).
Contact your doctor immediately for advice if your child has these symptoms.
- inflammation of the liver (hepatitis),
- jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellowish,
- inflammation of kidney tubules,
- delayed blood clotting,
- hyperactivity,
- seizures (in patients taking high doses of Augmentin or with kidney problems),
- black, hairy-looking tongue,
- tooth staining (in children), which usually disappears with brushing.
Adverse effects that may appear in blood or urine tests
- significant decrease in white blood cell count,
- low red blood cell count (haemolytic anaemia),
- crystals in urine causing acute kidney injury.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Amoxicillin/Clavulanic Acid Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP/CAD. The expiry date refers to the last day of the month indicated.
Before reconstitution:
Do not store above 30 °C.
After reconstitution:
The suspension may be stored for up to 7 days at a temperature between 2 °C and 8 °C (in the refrigerator).
After opening the cap, ensure that the inner seal of the bottle is intact and securely attached to the rim. Do not use if the seal is not intact.
Do not use this medicine if clumps of powder are visible in the vial before reconstitution.
Do not use the reconstituted suspension if its colour is not white or almost white.
Do not use this medicine if you notice a change in the colour of the suspension after reconstitution. This may occur if special storage precautions for the reconstituted suspension have not been followed: such a colour change indicates loss of medicinal activity.
IN THIS CASE, IT IS ESSENTIAL TO USE A NEW BOTTLE.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a pharmacy’s SIGRE point. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Amoxicillin/Clavulanic Acid Sandoz 100 mg/ml + 12.5 mg/ml powder for oral suspension EFG
- The active substances are: amoxicillin 100 mg as amoxicillin trihydrate and clavulanic acid 12.5 mg as potassium clavulanate per ml of reconstituted suspension.
- The other components (excipients) are: succinic acid, xanthan gum, anhydrous colloidal silica, aspartame (E951), flavour E99-294-55 (contains maltodextrin = glucose), hydrated colloidal silica.
Appearance of the medicine and contents of the pack
This medicine is presented as a powder for oral suspension in a bottle [10.5 g of powder corresponds to 60 ml of reconstituted oral suspension, i.e., 224 dose graduations (1 dose = 1 kg)] with an oral dosing syringe.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Sandoz GmbH
Biochemiestrasse, 10
6250 Kundl
Austria
or
SANDOZ S.A.S.,
49 Av. Georges Pompidou,
92300 Levallois-Perret
France
Date of the most recent review of this leaflet: March 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.
General advice regarding the use of antibiotics Antibiotics are used to treat bacterial infections. They are not effective against viral infections. Sometimes a bacterial infection does not respond to antibiotic treatment. One of the most common reasons this occurs is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic. Bacteria can become resistant to antibiotics for many reasons. Using antibiotics appropriately can reduce the likelihood of bacteria becoming resistant. When your doctor prescribes an antibiotic, it is intended solely for treating your current illness. Following the advice below will help you prevent the development of resistant bacteria that could make antibiotics ineffective:
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